1.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
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Child
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Child, Preschool
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Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome
2.Protective effect of sub-hypothermic mechanical perfusion combined with membrane lung oxygenation on a yorkshire model of brain injury after traumatic blood loss.
Xiang-Yu SONG ; Yang-Hui DONG ; Zhi-Bo JIA ; Lei-Jia CHEN ; Meng-Yi CUI ; Yan-Jun GUAN ; Bo-Yao YANG ; Si-Ce WANG ; Sheng-Feng CHEN ; Peng-Kai LI ; Heng CHEN ; Hao-Chen ZUO ; Zhan-Cheng YANG ; Wen-Jing XU ; Ya-Qun ZHAO ; Jiang PENG
Chinese Journal of Traumatology 2025;28(6):469-476
PURPOSE:
To investigate the protective effect of sub-hypothermic mechanical perfusion combined with membrane lung oxygenation on ischemic hypoxic injury of yorkshire brain tissue caused by traumatic blood loss.
METHODS:
This article performed a random controlled trial. Brain tissue of 7 yorkshire was selected and divided into the sub-low temperature anterograde machine perfusion group (n = 4) and the blank control group (n = 3) using the random number table method. A yorkshire model of brain tissue injury induced by traumatic blood loss was established. Firstly, the perfusion temperature and blood oxygen saturation were monitored in real-time during the perfusion process. The number of red blood cells, hemoglobin content, NA+, K+, and Ca2+ ions concentrations and pH of the perfusate were detected. Following perfusion, we specifically examined the parietal lobe to assess its water content. The prefrontal cortex and hippocampus were then dissected for histological evaluation, allowing us to investigate potential regional differences in tissue injury. The blank control group was sampled directly before perfusion. All statistical analyses and graphs were performed using GraphPad Prism 8.0 Student t-test. All tests were two-sided, and p value of less than 0.05 was considered to indicate statistical significance.
RESULTS:
The contents of red blood cells and hemoglobin during perfusion were maintained at normal levels but more red blood cells were destroyed 3 h after the perfusion. The blood oxygen saturation of the perfusion group was maintained at 95% - 98%. NA+ and K+ concentrations were normal most of the time during perfusion but increased significantly at about 4 h. The Ca2+ concentration remained within the normal range at each period. Glucose levels were slightly higher than the baseline level. The pH of the perfusion solution was slightly lower at the beginning of perfusion, and then gradually increased to the normal level. The water content of brain tissue in the sub-low and docile perfusion group was 78.95% ± 0.39%, which was significantly higher than that in the control group (75.27% ± 0.55%, t = 10.49, p < 0.001), and the difference was statistically significant. Compared with the blank control group, the structure and morphology of pyramidal neurons in the prefrontal cortex and CA1 region of the hippocampal gyrus were similar, and their integrity was better. The structural integrity of granulosa neurons was destroyed and cell edema increased in the perfusion group compared with the blank control group. Immunofluorescence staining for glail fibrillary acidic protein and Iba1, markers of glial cells, revealed well-preserved cell structures in the perfusion group. While there were indications of abnormal cellular activity, the analysis showed no significant difference in axon thickness or integrity compared to the 1-h blank control group.
CONCLUSIONS
Mild hypothermic machine perfusion can improve ischemia and hypoxia injury of yorkshire brain tissue caused by traumatic blood loss and delay the necrosis and apoptosis of yorkshire brain tissue by continuous oxygen supply, maintaining ion homeostasis and reducing tissue metabolism level.
Animals
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Perfusion/methods*
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Disease Models, Animal
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Brain Injuries/etiology*
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Swine
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Male
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Hypothermia, Induced/methods*
3.Mediating effect of sleep duration between depression symptoms and myopia in middle school students.
Wei DU ; Xu-Xiang YANG ; Ru-Shuang ZENG ; Chun-Yao ZHAO ; Zhi-Peng XIANG ; Yuan-Chun LI ; Jie-Song WANG ; Xiao-Hong SU ; Xiao LU ; Yu LI ; Jing WEN ; Dang HAN ; Qun DU ; Jia HE
Chinese Journal of Contemporary Pediatrics 2025;27(3):359-365
OBJECTIVES:
To explore the mediating role of sleep duration in the relationship between depression symptoms and myopia among middle school students.
METHODS:
This study was a cross-sectional research conducted using a stratified cluster random sampling method. A total of 1 728 middle school students were selected from two junior high schools and two senior high schools in certain urban areas and farms of the Xinjiang Production and Construction Corps. Questionnaire surveys and vision tests were conducted among the students. Spearman analysis was used to analyze the correlation between depression symptoms, sleep duration, and myopia. The Bootstrap method was employed to investigate the mediating effect of sleep duration between depression symptoms and myopia.
RESULTS:
The prevalence of myopia in the overall population was 74.02% (1 279/1 728), with an average sleep duration of (7.6±1.0) hours. The rate of insufficient sleep was 83.62% (1 445/1 728), and the proportion of students exhibiting depression symptoms was 25.29% (437/1 728). Correlation analysis showed significant negative correlations between visual acuity in both eyes and sleep duration with depressive emotions as measured by the Center for Epidemiologic Studies Depression Scale (with correlation coefficients of -0.064, -0.084, and -0.199 respectively; P<0.01), as well as with somatic symptoms and activities (with correlation coefficients of -0.104, -0.124, and -0.233 respectively; P<0.01) and interpersonal relationships (with correlation coefficients of -0.052, -0.059, and -0.071 respectively; P<0.05). The correlation coefficients for left and right eye visual acuity and sleep duration were 0.206 and 0.211 respectively (P<0.001). Sleep duration exhibited a mediating effect between depression symptoms and myopia (indirect effect=0.056, 95%CI: 0.029-0.088), with the mediating effect value for females (indirect effect=0.066, 95%CI: 0.024-0.119) being higher than that for males (indirect effect=0.042, 95%CI: 0.011-0.081).
CONCLUSIONS
Sleep duration serves as a partial mediator between depression symptoms and myopia in middle school students.
Humans
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Myopia/etiology*
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Male
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Female
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Depression/physiopathology*
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Cross-Sectional Studies
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Sleep
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Adolescent
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Students
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Child
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Time Factors
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Sleep Duration
5.Time trend analysis of the disease burden of colorectal cancer among young and middle-aged adults in China from 1990 to 2021
Jun CHEN ; Dandan TANG ; Yuxin ZHOU ; Yuting TAN ; Honglan LI ; Qun XU ; Yongbing XIANG
Journal of International Oncology 2025;52(8):508-516
Objective:To analyze the disease burden of colorectal cancer (CRC) among young and middle-aged people in China from 1990 to 2021, and to explore the influence of age, period and cohort on the incidence and mortality of CRC in young and middle-aged people of China.Methods:Data on CRC in patients aged 40-59 years in China from 1990 to 2021 were extracted from the Global Burden of Disease Study 2021 (GBD 2021) database. Statistics such as incidence rate, mortality rate, disability-adjusted life years (DALY), and their corresponding age-standardized rates were calculated to analyze the CRC incidence and mortality in different age and sex groups of young and middle-aged Chinese young people from 1990 to 2021. The Joinpoint regression model was used to analyze the CRC incidence, the mortality and the DALY rate, as well as to calculate the annual percentage change (APC) and the average annual percentage change (AAPC). The effects of three independent factors, namely age, period and cohort, on the incidence and mortality of CRC in young and middle-aged people of China were analyzed and evaluated through the age-period-cohort model.Results:From 1990 to 2021, there was a remarkable upward trend in the incidence, mortality, and DALY of CRC among Chinese young and middle-aged adults. In 2021, the number of incidence cases of CRC among young and middle-aged people in China reached 181 000, and the number of deaths reached 57 900, which were 236.80% and 75.48% higher than those in 1990 (53 800 and 33 000, respectively). During the same period, DALY increased by 62.59%, with the 55-59 age group having the largest increase at 83.35%. From 1990 to 2021, the age-standardized incidence rate (ASIR) increased by 49.04%, rising from 25.51/100 000 to 38.02/100 000, and the age-standardized mortality rate (ASMR) declined by 28.75%, decreasing from 17.01/100 000 to 12.12/100 000, respectively. The increase in ASIR was the greatest among the 40-44 age group, reaching 57.31%, while the decline in ASMR was the most significant among the 50-54 age group, amounting to 30.18%. However, the DALY rate declined by 26.66%, from 673.52/100 000 to 493.94/100 000. The decline in DALY was the greatest among the 50-54 age group, reaching 28.26%. Joinpoint regression model analysis showed that, from 1990 to 2021, the incidence of CRC in Chinese young and middle-aged adults rose on average by 1.32% annually, and the increase was higher in men (1.87%) than that in women (0.36%). The mortality rate showed a downward trend, with an average annual decline of 1.10%, with a higher decline in women than in men (-2.14% vs. -0.50%). The DALY rate showed a downward trend, with an average annual decline of 1.00%, and more decline in women than in men (-2.06% vs. -0.41%). All of these trends were statistically significant (all P<0.001). The age-period-cohort model analysis showed that, the net drift of CRC incidence was 1.21% (1.02%-1.41%) per year among Chinese young and middle-aged adults between 1990 and 2021, while the net drift in mortality was -1.40% (-1.59%--1.21%) per year. The impact of age on CRC incidence and mortality intensified with advancing age. Incidence attributable to age rose from 12.66% (11.90%- 13.46%) in the 40-44 age group to 56.68% (54.37%-59.08%) in the 55-59 age group. Similarly, mortality attributable to age increased from 6.47% (6.12%-6.85%) in the 40-44 age group to 25.74% (24.58%-26.96%) in the 55-59 age group. In all age groups, the role of CRC incidence and mortality attributable to age was higher in men than in women. Period effects on the RR value of CRC incidence showed a declining trend followed by an upward trend, with the highest risk during 2015-2019 ( RR=1.36, 95% CI: 1.28-1.43), using 2000-2004 as the reference. For mortality, period effects exhibited a declining trend, with the highest risk during 1990-1994 ( RR=1.23, 95% CI: 1.15-1.32), using 2000-2004 as the reference. Cohort effects indicated that later birth cohorts had higher incidence risks, with the highest incidence observed in the 1973-1977 birth cohort ( RR=1.30, 95% CI: 1.16-1.45), using the 1953-1957 birth cohort as the reference. Conversely, later birth cohorts had lower mortality risks, with the lowest mortality in the 1973-1977 birth cohort ( RR=0.78, 95% CI: 0.69-0.88), using the 1953-1957 birth cohort as the reference. Conclusions:From 1990 to 2021, the changes in the disease burden of CRC among young and middle-aged people in China are manifested as an increase in standardized incidence rate and a decrease in standardized mortality rate. Meanwhile, there are gender differences in the trend of temporal changes. Age, period and cohort all have a significant impact on the incidence and mortality trends of colorectal cancer in young and middle-aged people. Research on the etiology of CRC should be strengthened, and targeted prevention and control strategies should be formulated.
6.Effects of Yishen Gujing Kangyan Prescription on the Levels of Interleukin 18,Transforming Growth Factor β1,Anti-ds-DNA Antibody and Complement C3 in Patients with Lupus Nephritis of Qiand Yin Deficiency Type
Hai-Xiang LI ; Yong-Jie TANG ; Shi-Qun ZHOU ; Min YANG
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(3):575-582
Objective To investigate the clinical value of Yishen Gujing Kangyan Prescription(with the actions of benefiting the kidneys,consolidating essence and anti-inflammatory,mainly composed of Imperatae Rhizoma,Codonopsis Radix,Corni Fructus,Moutan Cortex,Lycii Fructus,Cuscutae Semen,Dioscoreae Rhizoma,honey-roasted Astragali Radix,Poria,Rehmanniae Radix Praeparata,etc.)in the treatment of lupus nephritis(LN)of qi and yin deficiency type.Methods A total of 116 patients with LN of qi and yin deficiency type were randomly divided into observation group and control group,58 cases in each group.The control group was given conventional western medicine treatment,and the observation group was treated with the combination of Yishen Gujing Kangyan Prescription on the basis of treatment for the control group.Both groups were treated for a period of 6 months.The changes of traditional Chinese medicine(TCM)syndrome scores,renal function parameters,immune function indicators,serum interleukin 18(IL-18),homocysteine(Hcy),transforming growth factor β1(TGF-β1),cystatin C(Cys C)levels in the two groups were observed before and after the treatment.After treatment,the clinical efficacy and the negative-conversion of anti-double-stranded DNA(ds-DNA)antibody were compared between the two groups.Results(1)After 6 months of treatment,the total effective rate of the observation group was 94.83%(55/58),and that of the control group was 75.86%(44/58).The intergroup comparison showed that the therapeutic effect of the observation group was significantly superior to that of the control group(χ2 = 5.453,P<0.05).(2)After treatment,the scores of primary symptoms(edema,fatigue)and secondary symptoms(lumbar and knee soreness,loose stools)in the two groups were lower than those before treatment(P<0.05),and the effect on lowering the scores in the observation group was significantly superior to that in the control group(P<0.01).(3)After treatment,the levels of renal function parameters of blood urea nitrogen(BUN),serum creatinine(Scr),and 24-hour urine protein quantification of the two groups were all lower than those before treatment(P<0.05),and the effect on lowering renal function parameters in the observation group was significantly superior to that in the control group(P<0.01).(4)After treatment,serum IL-18,TGF-β1,Hcy and Cys C levels of the two groups of patients were all reduced compared with those before treatment(P<0.05),and the effect on lowering the levels of inflammatory factors and fibrosis parameters in the observation group was significantly superior to that in the control group(P<0.01).(5)After treatment,the levels of immune function indicators of T cell subsets CD4+,CD4+/CD8+ and complement C3 in the two groups were increased compared with those before treatment(P<0.05),and the increase in the observation group was significantly superior to that in the control group,and the differences were all statistically significant(P<0.05 or P<0.01).(6)The negative-conversion rate of anti-ds-DNA antibody in the observation group was 77.59%(45/58),which was significantly higher than that in the control group(55.17%,32/58),and the difference was statistically significant between the two groups(P<0.05).Conclusion For the treatment of patients with LN of qi and yin deficiency type,Yishen Gujing Kangyan Prescription exerts synergistic effect on reducing inflammatory response,regulating immune function,promoting the recovery of renal function,and enhancing clinical efficacy.
7.Progress in Epidemiological Research on Relationship Between Duration of Type 2 Diabetes and Risk of Malignant Tumors of Female Reproductive System
Xiaohui ZHOU ; Zhuoying LI ; Wanwan LIU ; Peiwen LU ; Qiuming SHEN ; Qun XU ; Yongbing XIANG
Cancer Research on Prevention and Treatment 2024;51(12):977-988
The relationship between the duration of type 2 diabetes mellitus (T2DM) and the risk of female reproductive malignancies is complex and multifaceted. Large population cohort studies revealed a negative association between the duration of T2DM and the incidence of breast cancer and endometrial cancer. Furthermore, the risk of breast and endometrial cancer is the highest within a short time after T2DM diagnosis and remains remarkably higher in patients with longer diabetes duration than in the nondiabetic population. This phenomenon suggests causal reverse bias and potential detection bias. Nevertheless, T2DM remains an important risk factor for breast and
8.Long-Term Survival Trend of Gynecological Cancer:A Systematic Review of Population-Based Cancer Registration Data
Zhou XIAOHUI ; Yang DANNI ; Zou YIXIN ; Tang DANDAN ; Chen JUN ; Li ZHUOYING ; Shen QIUMING ; Xu QUN ; Xiang YONGBING
Biomedical and Environmental Sciences 2024;37(8):897-921
Gynecological cancer significantly affect the health of women.This review aimed to describe the global patterns and trends in the survival of patients with gynecological cancers.We searched PubMed,Embase,Web of Science,SinoMed,and SEER for survival analyses of cancer registration data of cervical,endometrial,and ovarian cancers published between 1980 and 2022.Globally,the highest 5-year observed survival rate for cervical cancer was 76.5%in Anshan,Liaoning,China(2008-2017).The 5-year observed survival rates of endometrial and ovarian cancers were higher in Finland(1995-1999,82.5%)and Singapore(1988-1992,62.0%).The 5-year relative survival rate of cervical cancer patients was higher in Haining,Zhejiang,China(2011-2014,85.8%).Korea ranked first at 89.0%and 64.5%for endometrial and ovarian cancers,respectively.Survival rates have improved for cervical,endometrial,and ovarian cancers.Patients aged≥75 years and those with advanced-stage disease had the worst 5-year survival rates.Survival rates were better for squamous cell carcinoma in cervical cancer,for endometrial carcinoma and mucinous adenocarcinoma in endometrial cancer,and for germ cell and sex-cord stromal tumors in ovarian cancer.Over the past four decades,the survival rates of gynecological cancers have increased globally,with notable increases in cervical and endometrial cancers.Survival rates are higher in developed countries,with a slow-growing trend.Future studies should focus on improving survival,especially in ovarian cancer patients.
9.In vitro expression and functional analyses of the mutants p.R243Q,p.R241C and p.Y356X of the human phenylalanine hydroxylase
Yong-Hong PANG ; Xiang-Yu GAO ; Zhen-Ya YUAN ; Hui HUANG ; Zeng-Qin WANG ; Lei PENG ; Yi-Qun LI ; Jie LIU ; Dong LIU ; Gui-Rong CHEN
Chinese Journal of Contemporary Pediatrics 2024;26(2):188-193
Objective To study the in vitro expression of three phenylalanine hydroxylase(PAH)mutants(p.R243Q,p.R241C,and p.Y356X)and determine their pathogenicity.Methods Bioinformatics techniques were used to predict the impact of PAH mutants on the structure and function of PAH protein.Corresponding mutant plasmids of PAH were constructed and expressed in HEK293T cells.Quantitative reverse transcription polymerase chain reaction was used to measure the mRNA expression levels of the three PAH mutants,and their protein levels were assessed using Western blot and enzyme-linked immunosorbent assay.Results Bioinformatics analysis predicted that all three mutants were pathogenic.The mRNA expression levels of the p.R243Q and p.R241C mutants in HEK293T cells were similar to the mRNA expression level of the wild-type control(P>0.05),while the mRNA expression level of the p.Y356X mutant significantly decreased(P<0.05).The PAH protein expression levels of all three mutants were significantly reduced compared to the wild-type control(P<0.05).The extracellular concentration of PAH protein was reduced in the p.R241C and p.Y356X mutants compared to the wild-type control(P<0.05),while there was no significant difference between the p.R243Q mutant and the wild type control(P>0.05).Conclusions p.R243Q,p.R241C and p.Y356X mutants lead to reduced expression levels of PAH protein in eukaryotic cells,with p.R241C and p.Y356X mutants also affecting the function of PAH protein.These three PAH mutants are to be pathogenic.[Chinese Journal of Contemporary Pediatrics,2024,26(2):188-193]
10.Establishment of a new classification system for distal clavicle fracture and its clinical efficiency evaluation
Cheng XUE ; Xingguo ZHENG ; Xiang LI ; Lijun SONG ; Xiaodong QIN ; Tianrun LYU ; Qun CHEN ; Kaixiao XUE ; Jiahu FANG
Chinese Journal of Trauma 2024;40(6):539-546
Objective:To establish a new classification system for distal clavicle fracture and evaluate its clinical effectiveness.Methods:A retrospective case series study was conducted to analyze the clinical data of 101 patients with distal clavicle fracture admitted to First Affiliated Hospital of Nanjing Medical University from January 2015 to March 2022, including 57 males and 44 females, aged 19-86 years [(53.8±14.0)years]. Before treatment, patients were routinely subjected to bilateral anteroposterior radiography of the shoulder joints to measure the length of the fractured fragments, coracoclavicular distance, and acromioclavicular distance. According to the correlation between the location of the fracture line and the insertion of the coracoclavicular ligament, distal clavicle fracture was divided into three types: type I, with the fracture line lateral to the coracoclavicular ligament region; type II, with the fracture line in the coracoclavicular ligament region; type III, with the fracture line medial to the coracoclavicular ligament region. According to the injury severity of the coracoclavicular ligament and acromioclavicular ligament, type I was further subdivided into type IA, IB, IC and ID, and type II fracture was further subdivided into type IIA, IIB, IIC, IID and IIE. All the 101 patients were classified and randomly reclassified at an interval of 3 months by 10 senior and 10 junior shoulder surgeons according to the new classification method. Kappa coefficients were used to evaluate the inter- and intra-observer consistency of the new classification. Fifty-two patients with stable fracture (types IA, IB, IIC, and IID) were treated non-surgically, while 49 patients with unstable fracture (types IC, ID, IIA, IIB, IIE, and III) were treated surgically, including 26 patients with anatomic coracoclavicular ligament reconstruction, 9 with locking plate fixation, 8 with clavicle hook plate fixation, 4 with anatomic coracoclavicular ligament reconstruction combined with locking plate fixation, and 2 with anatomic coracoclavicular ligament reconstruction combined with tension screw fixation. The patients were assessed using the visual analogue scale (VAS) and Constant-Murley shoulder score before treatment and at 3, 6, 12, and 18 months after treatment. The coracoclavicular distance and acromioclavicular distance on the anteroposterior radiographs of the healthy and affected shoulder joints were measured at 3, 6, 12, and 18 months after treatment, and fracture healing time and complications were observed.Results:The length of the fractured fragments was 12.9 (9.7, 17.6)mm in patients with type I fracture, 24.7 (21.8, 27.8)mm in patients with type II fracture, and 43.6 (41.2, 46.9)mm in patients with type III fracture ( P<0.01). There were no significant differences in the coracoclavicular distance and acromioclavicular distance of the affected and healthy shoulders among the patients with types IA, IB, IIC, IID, and III fracture ( P>0.05); For the patients with types IC, IIA, IIB and IIE fracture, the coracoclavicular distance of the affected shoulder was significantly increased compared with that of the healthy shoulder ( P<0.01), while there was no significant difference in the acromioclavicular distance of the affected and healthy shoulders ( P>0.05). Both of the inter- and intra-observer consistency of the new classification was good. The inter- and intra-observer Kappa values were 0.69 and 0.71 respectively among the senior shoulder surgeons, and 0.61 and 0.64 respectively among the junior shoulder surgeons. All the patients were followed up for 18-104 months [28(23, 32)months]. At 3, 6, 12 and 18 months after treatment, the VAS scores of non-surgical patients were 3(2, 3)points, 2(1, 2)points, 1(0, 1)points and 0(0, 1)points respectively, significantly decreased compared with 6(5, 6)points before treatment ( P<0.01); the VAS scores of surgical patients were 3(2, 3)points, 2(1, 2)points, 1(1, 1)points and 0(0, 1)points respectively, significantly decreased compared with 6(5, 7)points before treatment ( P<0.01); the Constant-Murley shoulder scores of non-surgical patients were (76.6±5.3)points, (84.3±5.0)points, (88.4±4.0)points and (91.9±3.8)points respectively, significantly higher than (42.7±5.2)points before treatment ( P<0.01); the Constant-Murley shoulder scores of surgical patients were (77.4±4.6)points, (84.4±4.7)points, (87.6±3.7)points and (91.7±4.0)points respectively, significantly higher than (42.8±5.3)points before treatment ( P<0.01). At 3, 6, 12 and 18 months after treatment, the coracoclavicular distance of the affected shoulder in non-surgical patients was not significantly different from that before treatment ( P>0.05), while the acromioclavicular distance of the affected shoulder in surgical patients was significantly reduced compared with that before treatment ( P<0.01). There were no significant differences in the coracoclavicular distance of the healthy shoulder or bilateral acromioclavicular distance in non-surgical and surgical patients at 3, 6, 12, and 18 months after treatment compared with those before treatment ( P>0.05). Fractures were healed within 12 months after treatment in all the patients, without dislocation or subluxation of the acromioclavicular joint, internal fixation failure or internal fixator breakage. Eight patients treated with clavicular hook plate fixation had shoulder pain associated with limited mobility after operation, and all underwent a second operation to remove the clavicular hook plate at 12 months after operation. Conclusions:The new classification system for distal clavicle fracture is established, which comprehensively considers the position of the fracture line, injury of the coracoclavicular and acromioclavicular ligaments, and fracture stability. The new classification system exhibits good inter- and intra- observer consistency, and the effectiveness of its preliminary clinical application is satisfactory.

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